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Lenalidomide - Generic Drug Details

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Lenalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and forty-two patent family members in forty-five countries.

There are nine drug master file entries for lenalidomide. One supplier is listed for this compound.

Summary for Generic Name: lenalidomide

Tradenames:1
Patents:27
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packagers: see list1
Bulk Api Vendors: see list87
Clinical Trials: see list465
Patent Applications: see list329
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lenalidomide at DailyMed

Pharmacology for Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo6,908,432► subscribe ► subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005RXYesNo► subscribe► subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005RXYesNo8,648,095► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 20136,281,230► subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 20068,288,415► subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 20057,119,106► subscribe
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Non-Orange Book Patents for Generic Ingredient: lenalidomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,863,297Methods of using 4-(amino)-2-(2,6-dioxo(3-piperidly))-isoindoline-3-dione for the treatment of myelodysplastic syndromes► subscribe
8,263,637Methods for treatment of multiple myeloma using cyclopropane carboxylic acid {2-[(is)-1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-3-ox- o-2,3-dihydro-1 h-isoindol-4-yl}-amide► subscribe
8,193,219Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: lenalidomide

Country Document Number Estimated Expiration
Taiwan200501945► subscribe
Germany69825994► subscribe
Japan2002501536► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LENALIDOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C033/2007Ireland► subscribeSPC033/2007: 20080507, EXPIRES: 20220613
2 50002-2015Slovakia► subscribePRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
0150005 00140Estonia► subscribePRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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